Stryker Howmedica Osteonics Corp. recalls Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mat…

Recall date

February 27, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1614-2015

FDA classification

Class II

Brand / firm

Stryker Howmedica Osteonics Corp.

Sold / distributed

US Nationwide distribution in the states of MA and RI.

Why it was recalled

Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.